Application 071108

Type: ANDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLURAZEPAM HYDROCHLORIDE	FLURAZEPAM HYDROCHLORIDE	CAPSULE;ORAL	30MG	No	No
002	FLURAZEPAM HYDROCHLORIDE	FLURAZEPAM HYDROCHLORIDE	CAPSULE;ORAL	15MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071108-001	FLURAZEPAM HYDROCHLORIDE	FLURAZEPAM HYDROCHLORIDE	30MG	CAPSULE / ORAL			1986-12-08
A071108-002	FLURAZEPAM HYDROCHLORIDE	FLURAZEPAM HYDROCHLORIDE	15MG	CAPSULE / ORAL			1986-12-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A071108-001	FLURAZEPAM HYDROCHLORIDE	30MG	CAPSULE / ORAL	1986-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071108-001	FLURAZEPAM HYDROCHLORIDE	30MG	CAPSULE / ORAL	1986-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071108-001	FLURAZEPAM HYDROCHLORIDE	30MG	CAPSULE / ORAL	1986-12-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071108-001	FLURAZEPAM HYDROCHLORIDE	30MG	CAPSULE / ORAL	1986-12-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071108-001	FLURAZEPAM HYDROCHLORIDE	30MG	CAPSULE / ORAL	1986-12-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071108-001	FLURAZEPAM HYDROCHLORIDE	30MG	CAPSULE / ORAL	1986-12-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A071108-001	FLURAZEPAM HYDROCHLORIDE	30MG	CAPSULE / ORAL	1986-12-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A071108-002	FLURAZEPAM HYDROCHLORIDE	15MG	CAPSULE / ORAL	1986-12-08	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flurazepam Hydrochloride	FLURAZEPAM HYDROCHLORIDE	Chartwell RX, LLC	8f476891-1346-4e8c-ac1b-f8cbdc64f5a1	2024-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Flurazepam Hydrochloride generic name: FLURAZEPAM HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-3370	Flurazepam	Flurazepam Hydrochloride	West-ward Pharmaceutical Corp	ANDA	Current
21695-363	Flurazepam	Flurazepam Hydrochloride	Rebel Distributors Corp	ANDA	Current
52959-236	Flurazepam	Flurazepam Hydrochloride	H.J. Harkins Company, Inc.	ANDA	Current
68788-0408	Flurazepam	Flurazepam Hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current